NCT07718295 HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
| NCT ID | NCT07718295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Firat University |
| Condition | Procedural Sedation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * American Society of Anesthesiologists physical status I-IV * Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting * Ability to provide written informed consent * Willingness to participate in the study Exclusion Criteria: * Age younger than 18 years * Refusal or inability to provide written informed consent * Known neurological disorders * History of ischemic or hemorrhagic stroke * History of traumatic brain injury or previous cranial surgery * Peripheral arterial disease or systemic vasculitis * Advanced heart failure * Uncontrolled hypertension * Uncontrolled diabetes mellitus * Advanced chronic obstructive pulmonary disease (COPD) * Severe anemia (hemoglobin \<8 g/dL) * Skin lesions or other conditions preventing proper placement of NIRS sensors * Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy * Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07718295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Procedural Sedation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07718295 currently recruiting?
Yes, NCT07718295 is actively recruiting participants. Contact the research team at drahmetaksu@gmail.com for enrollment information.
Where is the NCT07718295 trial being conducted?
This trial is being conducted at Elâzığ, Turkey (Türkiye).
Who is sponsoring the NCT07718295 clinical trial?
NCT07718295 is sponsored by Firat University. The trial plans to enroll 100 participants.